Abstract

In this study, an easy to use measurement method was developed to quantify the balloon dilatation catheters visibility, thus making them comparable. The visibility of the distal and proximal markers and the balloon (average values of the markers) was determined for fourteen balloons of the same type and material, but different lengths and diameters. Repeatability of these values was tested by one volunteer and reproducibility by two volunteers three times each for all the balloons used for the study. It was found that the average visibility for balloons was 12±2%, 13±2% for distal markers, and 13±2% for proximal markers. Values of distal and proximal markers did not represent significant difference (p=0.20). There was no significant difference determined for repeatability and reproducibility either (p values were between 0.71-0.93). Hence, the developed measurement method was repeatable and reproducible making it suitable for comparison of the balloon dilatation catheters based on visibility.

Highlights

  • Cardiovascular diseases are the number one cause of death worldwide. 41% of death is caused by ischaemic heart disease and 35% by stroke [1]

  • 3 Results The average visibility measurements conducted by the first volunteer were 12±2% (CV=0.16) for all the fourteen distal markers, 13±2% (CV=0.18) for all the fourteen proximal markers and 13±2% (CV=0.17) for the balloon catheters

  • The average visibility of the proximal markers compared with the first background segment was 13±2% (CV=0.18); 13±2% (CV=0.18) with the second background segment; 13±2% (CV=0.13) with the third background segment

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Summary

Introduction

Cardiovascular diseases are the number one cause of death worldwide. 41% of death is caused by ischaemic heart disease and 35% by stroke [1]. 41% of death is caused by ischaemic heart disease and 35% by stroke [1]. These emergences are caused by stenosis or occlusion of the vessels in the heart or brain [2]. One of the potential medical devices used for the dilatation of the vascular system is the balloon dilatation catheter [3]. Balloon (average of the Proximal → marker markers). X-ray images of the balloons were taken by Dage XiDAT XD6600 X-ray Inspection System. The greyscale images of the two markers (Fig. 1b-1c) and some parts of the background (Fig. 1d), which did not contain the balloon catheter but located close to the balloon or marker, were taken using an image-editing program (Gimp 2). If the comparable images are close to each other, these errors can manifest

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